MODIFICATION OF BIONECT HYDROGEL FOAM

K984267 · Fidia Pharmaceutical Corp. · MGQ · Feb 10, 1999 · SU

Device Facts

• Record ID: K984267
• Device Name: MODIFICATION OF BIONECT HYDROGEL FOAM
• Applicant: Fidia Pharmaceutical Corp.
• Product Code: MGQ · SU
• Decision Date: Feb 10, 1999
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

BIONECT® Hydrogel Foam provides a moist wound environment that is supportive to wound healing. It indicated for the dressing and management of minor burns; superficial cuts, lacerations, and abrasions; and minor irritations of the skin. A health care professional may be consulted prior to the first use of this product to determine whether these conditions exist. BIONECT® Hydrogel Foam may also be used under the care of a health care professional for wounds such as partial to full thickness dermal ulcers (pressure ulcers, venous stasis ulcers, arterial ulcers, diabetic ulcers), surgical wounds (post-opcrative incisions and donor sites), and second degree burns,

Device Story

BIONECT® Hydrogel Foam is a white hydrogel dressing composed of sodium hyaluronate and purified water; designed to provide a moist, soothing wound environment. Used for management of various wounds including minor burns, abrasions, and chronic ulcers. Applied topically to the wound site; may be used by patients or under the care of a healthcare professional. Sodium hyaluronate acts as a biopolymer to increase gel viscosity. Device supports healing by maintaining moisture; does not accelerate healing or act as a permanent skin substitute. Clinical safety supported by trials of related BIONECT hydrogel products.

Clinical Evidence

No clinical data specific to the foam version provided. Safety is supported by 22 clinical trials (17 controlled) conducted in Europe on related BIONECT Hydrogel and BIONECT Hydrogel Gauze Pads in patients with ulcers, burns, and surgical wounds. Bench testing included in vitro and in vivo biocompatibility testing (cytotoxicity, dermal irritation, and dermal sensitization).

Technological Characteristics

White hydrogel foam dressing; materials: sodium hyaluronate (polysaccharide biopolymer) and purified water. Functions as a non-interactive wound dressing to provide a moist environment. No active energy source or software components.

Indications for Use

Indicated for dressing and management of minor burns, superficial cuts, lacerations, abrasions, and minor skin irritations. Also indicated for use under professional care for partial to full thickness dermal ulcers (pressure, venous stasis, arterial, diabetic), surgical wounds (incisions, donor sites), and second-degree burns.

Predicate Devices

• BIONECT® Hydrogel

Reference Devices

• BIONECT® Hydrogel Gauze Pads
• BIONECT® Clear Hydrogel
• BIONECT® Hydrogel Spray

Submission Summary (Full Text)

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る202 833 7057 13:00

02/01/99

# fidia Pharmacoutical Corporation

**February 1, 1999**

### 10. 510(k) SUMMARY

Summary Information 10.1

10.1.1 Submitter's name and address

FIDIA Pharmaceutical Corporation 2000 K Street, NW, Suite 700 Washington, DC 20006

Contact person and telephone number:

Roberto Fiorentini, M.D., President Telephone: [phone] [phone] Telefax:

Date summary was prepared:

February 1, 1999

## 10.1.2 Name of the Device

Trade Name: Common Name: Classification Name:

BIONECT® Hydrogel Foam Hyaluronic acid sodium salt hydrogel dressing Hydrogel Wound and Burn Dressing

2031

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# 10.1.3 Identification of predicate device to which substantial equivalence is being claimed

BIONECT® Hydrogel Foam is substantially equivalent in function and intended use to the following cleared non-interactive wound and burn dressing: BIONECT® Hydrogel.

## 10.1.4 Device description

Explanation of how the device functions: Since it is a hydrogel, BIONECT" Hydrogel Foam provides a moist wound environment that is supportive to wound healing.

Basic scientific concepts that form the basis for the device: BIONECT Hydrogel Foam was designed to provide a soothing, moist environment that is supportive to wound healing.

Significant physical and performance characteristics of the device such as device design. materials used, and physical properties: BIONECT® Hydrogel Foam is a white foam that is prepared from sodium hyaluronate and purified water to form a hydrogel dressing. Sodium hyaluronate is a polysaccharide biopolymer that can increase the viscosity of the gel. BIONECT® Hydrogel Foam, since it is a hydrogel dressing, provides a soothing, moist environment that is supportive to wound healing.

# 10.1.5 Statement of the intended use of the device, including general description of the conditions the device will mitigate and the patient population for which the device is intended

BIONECT® Hydrogel Foam provides a moist wound environment that is supportive to wound healing. It indicated for the dressing and management of minor burns; superficial cuts, lacerations, and abrasions; and minor irritations of the skin. A health care

8

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# 1012 Pharmaceutical Corporation

Statement of the intended use of the device, including general description of the conditions the device will mitigate and the patient population for which the device is intended

BIONECT® Hydrogel Foam provides a moist wound environment that is supportive to wound healing. It indicated for the dressing and management of minor burns; superficial cuts, lacerations, and abrasions; and minor irritations of the skin. A health care professional may be consulted prior to the first use of this product to determine whether these conditions exist. BIONECT® Hydrogel Foam may also be used under the care of a health care professional for wounds such as partial to full thickness dermal ulcers (pressure ulcers, venous stasis ulcers, arterial ulcers, diabetic ulcers), surgical wounds (post-opcrative incisions and donor sites), and second degree burns,

These indication statements are not different from the predicate device identified in paragraph (3) of this section.

# 10.1.6 Statement of how the technological characteristics of the device compare to those of the predicate device

The technological characteristics of the device such as form, occlusion, conformability, bioburden level, moist wound healing, and appearance in the wound when hydrated are not different from the predicate device cited.

### 10.2 Assessment of performance data

In vitro and in vivo biocompatibility testing (cytotoxicity, dermal irritation, and dermal sensitization tests) has been performed on BIONECT® Hydrogel Foam settled foam in

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# a Pharmaceutical Corporation

210

Clinical experience with BIONECT® Hydrogel and BIONECT® Hydrogel Gauze Pads in 22 clinical trials (17 controlled) conducted in Europe in patients with various types of ulcers, burns, and surgical wounds indicates that BIONECT® Hydrogel Foam is safe for its intended use.

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Public Health Service

Image /page/4/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

FEB 10 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Roberto Fiorentini President Fidia Pharmaceutical Corp. 2000 K Street, N.W. - Suite 700 Washington, D.C. 20006

Re: K984262-BIONECT Hydrogel Gauze Pads K984264-BIONECT Clear Hydrogel K984266-BIONECT Hydrogel Spray K984267-BIONECT Hydrogel Foam K984413-BIONECT Hydrogel Regulatory Class: Unclassified Product Code: MGQ Dated: November 17, 1998 Received: November 17, 1998

Dear Mr. Fiorentini:

We have reviewed your Section 510(k) notifications of intent to market the devices referenced above and we have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act). You may, therefore, market your devices subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:

- These devices may not be labeled for use on third degree burns. 1.
- These devices may not be labeled as having any accelerating effect on the rate of 2. wound healing or epithelization.
- 3. These devices may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
- These devices may not be labeled as a treatment or a cure for any type of wound. 4.

The labeling claims listed above would be considered a major modification in the intended use of the devices and would require a premarket notification submission (21 CFR 807.81).

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### Page 2 - Mr. Roberto Fiorentini

The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.

If vour devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submissions does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notifications. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its tollfree number [phone] or 301-443-6597 or at its internet address http://www.fda.gov/cdrh/dsmamain.html.

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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-HX NU. : L7R7CC+1C

# 112 Pharmaceutical Corporation

## February 1, 1999

### INDICATIONS FOR USE 2.

510(k) Number (if known): K984413 (Previously K963004) K984262 (Previously K973721) K984267 (Previously K973722) K984266 (Previously K973725) K984264 (Previously K973725)

Devicc Name:

BIONECT® Hydrogel BIONECT® Hydrogel Gauze Pads BIONECT® Hydrogel Foam BIONECT® Hydrogel Spray BIONECT® Clear Hydrogel

Indications for Use:

BIONECT Hydrogel, Gauze Pads, Foam, Spray, and Clear Hydrogel are indicated for the dressing and management of minor burns: superficial cuts, lacerations, and abrasions; and minor irritations of the skin. A health care professional may be consulted prior to the first use of these products to determine whether these conditions exist. BIONECT Hydrogel, Gauze Pads, Foam, Spray, and Clear Hydrogel may also be used under the care of a health care professional for wounds such as partial to full thickness dermal ulcers (pressure ulcers, venous stasis ulcers, arterial ulcers, diabetic ulcers), surgical wounds (post-operative incisions and donor sites), and second degree burns.

### PLEASE DO NOT WRITE BELOW THIS LINE ~ CONTUNUE. ON ANOTHER PAGE IF NEIJDED Concurrence of CDRH, Office of Device Evaluation (ODE)

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Prescription Use (Per 21 CRF 801.109)

Over-the-Counter Use X

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(Division Sign-Off)
Division of General Restorative Devices
510(k) Number
K984262, K984264, K984266,
K984267, K984413

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